Hydrocortisone Acetate (hye-droe-KOR-ti-sone AS-e-tate), Pramoxine Hydrochloride (pram-OX-een hye-droe-KLOR-ide)

Relieves pain, itching, and swelling caused by skin diseases. This medicine contains a corticosteroid.

Brand Name(s):

Analpram HC, Epifoam, Pramosone, ProCort, Proctofoam-HC

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream, Foam, Lotion, Ointment

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use on the skin only. Do not get any of it in your eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.
• .Wash your hands with soap and water before and after you use this medicine.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Foam:
  • Shake the aerosol can just before using. Hold the can 3 to 6 inches from the skin and spray for about 2 seconds. Hold the can upright and prime it by pressing the cap for a few times until foam appears.
  • Disassemble the container and cap and rinse with warm water after use.
  • Do not inhale this medicine or use it near heat or an open flame. Do not puncture, break, or burn the aerosol can.
• Lotion: Shake well before using.
• Do not cover the treated area with a bandage unless directed by your doctor. Do not cover the treated skin with tight-fitting diapers or plastic pants if you are using this medicine on a child's diaper area.
• This medicine is not for long-term use.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate the aerosol foam can.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not put cosmetics or skin care products on the treated skin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, adrenal gland problems (including Cushing syndrome), diabetes, or any type of skin infection.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• This medicine may cause the following problems:
  • Adrenal or pituitary gland problems
  • Serious skin reactions, which may occur if you cover the treated skin area or use the medicine for a long time
• This medicine may delay growth in children. If you think your child is not growing properly while using this medicine, talk with your doctor.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or pus on the treated skin areas
• Confusion, headache, vision changes, increased pressure in the head
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Increased hair growth on the forehead, back, arms, and legs
• Mild burning, dryness, irritation, redness, or itching of the skin
• Severe skin itching, burning, redness, peeling, or pain
• Thinning of the skin
• Weight gain around your neck, upper back, breast, face, or waist

If you notice these less serious side effects, talk with your doctor:

• Acne or pimples

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088